The FDA’s change in position was outlined in a letter from Denise Hinton, the agency’s chief scientist, to Gary Disbrow, the acting director of the Biomedical Advanced Research and Development Authority, who requested the revocation. The FDA noted in the letter that the request was an “interagency effort” prompted by new clinical trial results and other information.
The drug is still approved for lupus and arthritis, and the FDA action does not affect that.
Monday’s action comes after months of questions and criticisms about the FDA’s authorization of the products for covid-19 on March 28. Within weeks of the authorization, the FDA issued a safety warning, noting the drugs could cause heart-rhythm problems and saying the medication should be used only in the hospital setting or in clinical trials.
For months, Trump touted hydroxychloroquine as a “game changer.” It was also talked up by many of his close associates, such as Rudolph W. Giuliani. The president toned down his public enthusiasm for the drug after the heart warning, but said he took a course of it after two aides in the White House tested positive for the coronavirus.
But clinical trials have failed to show the drugs are effective in preventing or treating covid-19. A trial being conducted in the United Kingdom was halted in early June because of the lack of evidence that hydroxychloroquine provided a benefit to hospitalized patients.
“Hydroxychloroquine and chloroquine have received a lot of attention and have been used very widely to treat COVID patients despite the absence of any good evidence,” Peter Horby, chief investigator for the trial and professor of emerging infectious diseases and global health at the University of Oxford said in a statement then. “Although it is disappointing that this treatment has been shown to be ineffective, it does allow us to focus care and research on more promising drugs.”
A trial conducted by University of Minnesota researchers showed the drug was not effective in preventing covid-19 in people exposed to the virus. A large clinical trial published in The Lancet also showed the drug increased the risk of death but that study was retracted after questions arose about the underlying hospital data.
The promotion of hydroxychloroquine in the absence of evidence and the designation of the emergency use authorization has become a scientific flash point. Critics, who have included past leaders of the FDA, argued that what was at stake was much bigger than emergency authorization of one drug, but the public’s ability to trust the federal response to the pandemic.
“Not only are there potential negative consequences from uncontrolled use of these drugs based on currently unconvincing data but, equally concerning, the integrity of governmental decision-making is increasingly coming under pressure, risking harm to both patients and to the public confidence needed to respond effectively to this pandemic,” two former chief scientists for the FDA wrote in a viewpoint article in the Journal of the American Medical Association.
One of those co-authors welcomed the FDA withdrawal of the emergency authorization on Monday. “It’s the right thing to do. It’s very overdue,” said Luciana Borio, the former director for medical and biodefense preparedness policy at the U.S. National Security Council and a former chief scientist at the FDA. “This should have never been issued.”
The standard of evidence used for emergency use authorizations is much lower standard of evidence than that for full FDA approval. Such authorizations also are temporary, in effect only during a public health emergency.
Doctors still will be able to prescribe the drug to covid-19 patients “off label,” if they choose. But the chloroquine that had been authorized by the FDA does not have approval in the United States and can’t be used for other purposes. Both were donated to the government by pharmaceutical companies.
Anand Shah, FDA deputy commissioner for medical and scientific affairs, said in a statement that the agency’s actions “will be guided by science and that our decisions may evolve” as more is learned about the virus and new evidence is available.
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